5 December 2025
From the regulatory newsfeed of the Medicines and Healthcare products Regulatory Agency (MHRA), Arex Advisor has rounded up a selection of highlights from November 2025.
Expert highlights key principles for regulating AI in healthcare
19 November 2025
Professor Alastair Denniston sets out core principles to guide how artificial intelligence should be regulated as it becomes increasingly embedded in clinical practice. His perspective underscores the need for clear, reliable, and patient-centred oversight to ensure safe and effective use of AI-driven technologies in healthcare. Read more
MHRA offers tailored regulatory advice for medical and IVD devices
3 December 2025
The MHRA has outlined how developers can request regulatory advice meetings for medical devices and in vitro diagnostics, particularly where existing guidance is difficult to apply. The service helps organisations clarify regulatory expectations early, supporting smoother development and assessment of innovative technologies. Read more
How do these changes affect you?
Our experienced specialists are ready to help you navigate the regulatory landscape!